Quality Assurances SOPs List

Quality Assurances SOPs List

SNo. SOP Title
01 SOP on validation master plan
02 SOP on Function of quality assurance department
03 SOP on periodic physical observation of control sample
04 SOP on job responsibility of personnel working in quality assurance.
05 SOP on in-process sampling and analysis of oral drug products.
06 SOP on in-process checks during dry powder injection manufacturing & packing
07 SOP on dossier numbering
08 SOP on post packing check of finished product before transfer to warehouse
09 SOP on allocation of Bar Code
10 SOP on document management system in quality assurance department
11 SOP on preparation of Site Master File.
12 SOP on preparation, review, approval, distribution, control, & revision of sop.
13 SOP on document numbering and data control.
14 SOP on equipment / instrument numbering
15 SOP on change control procedure
16 SOP on handling of deviations
17 SOP on training to employee
18 SOP on document entries
19 SOP on disinfectant usage policy
20 SOP on handling of non- conformance report
21 SOP on issue and control of formats.
22 SOP on scrap handling policy.
23 SOP on destruction policy of drug products & its components.
24 SOP on internal quality audit   (self inspection)
25 SOP on job description /responsibilities to all the employees
26 SOP on specimen signature to all employees.
27 SOP on Product Recall
28 SOP on Annual Product Quality  Review
29 SOP on operation of Xerox cum scan machine
30 SOP on intimating all departments for reviewing of SOP.
31 SOP on department room numbering for the formulation plant
32 SOP on AHU numbering
33 SOP on AHU grill numbering.
34 SOP on corrective and preventive action (CAPA)
35 SOP on Transfer of Technology for Manufacturing process
36 SOP on rectification of errors
37 SOP on Transfer of Technology for Analytical Method
38 SOP on batch numbering of drug products.
39 SOP on review, audit and storage of batch records and testing records.
40 SOP on release of finished product.
41 SOP on monitoring of temperature, RH and pressure differential.
42 SOP on line clearance.
43 SOP on operation of disintegrator tester.
44 SOP on cleaning of disintegration test apparatus.
45 SOP on calibration of disintegration test apparatus.
46 SOP on operation of friability test apparatus.
47 SOP on cleaning of friability test apparatus.
48 SOP on calibration of friability test apparatus
49 SOP on operation of leak test apparatus
50 SOP on cleaning of leak test apparatus.
51 SOP on operation of analytical balance
52 SOP on cleaning of analytical balance
53 SOP on operation of hardness tester.
54 SOP on cleaning of hardness tester.
55 SOP on operation of vernier caliper.
56 SOP on cleaning of vernier caliper.
57 SOP on operation of moisture analyzer
58 SOP on cleaning of moisture analyzer
59 SOP on Vendor approval for raw material
60 SOP on Raw Material code Numbering System and its applicability
61 SOP on Handling of market Complaints
62 SOP on Handling, Investigation and Reporting  of out of Specification (OOS) Result
63 SOP on Design Qualification Guideline for minimizing the Risk of Product Cross Contamination of factory equipment and process.
64 SOP on batch numbering system for trial batches.
65 SOP on writing & approval of validation protocol & reports.
66 SOP on review of batch processing and control record.
67 SOP on rounding off the quantity of ingredients in the formula.
68 SOP on maintaining equipment/instrument log book.
69 SOP on approval of art work print proof and shade card of printed packaging material.
70 SOP on equipment operation, cleaning & maintenance of log book
71 SOP on in Process labelling and its format numbering
72 SOP sampling of bulk & finished product, rinse, swab test for testing
73 SOP on Preparation, review, approval, distribution, control and revision of Specifications, Standard test procedures and General test procedure.
74 SOP on preparation, control, issuance and revision of batch manufacturing and batch packing records.
75 SOP on reprocessing & rework due to non-conformance of the product
76 SOP on withdrawal, storage, observation & destruction of control / retention sample.
77 SOP on packing material code numbering system and its applicability
78 SOP on Maximum Retail Price list for finished products
79 SOP on standard Packing Material Specification
80 SOP on vendor approval for Packaging Material
81 SOP on calibration of analytical balance
82 SOP on control of labels, tags, log books and registers
83 SOP on Product failure Investigation
84 SOP on procedure for monitoring of compresses air.
85 SOP on code numbering system of utility and miscellaneous products.
86 SOP on verification of sampling dies
87 SOP on initiation and reviewing of Manufacturing Master formula (MFC )
88 SOP on sampling of rinse and swab samples after equipment cleaning
89 SOP on Sieve Numbering
90 SOP on Screen Numbering

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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